Multimodal Therapy for Somatosensory Tinnitus (NCT07468318) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Therapy for Somatosensory Tinnitus
Czechia160 participantsStarted 2027-01-01
Plain-language summary
Tinnitus (ringing or buzzing in the ears) affects approximately 10-15% of the adult population and significantly reduces quality of life in many patients. In a substantial proportion of cases, tinnitus is associated with dysfunction of the temporomandibular joint (TMJ) and cervical spine - this subtype is called somatosensory tinnitus.
This randomised controlled trial investigates the effectiveness of a multimodal intervention combining: (1) physiotherapy targeting TMJ and cervical spine dysfunction, (2) a structured combined exercise program (aerobic + resistance + breathing), and (3) psychological support (cognitive-behavioural psychoeducation) in patients with chronic somatosensory tinnitus.
The study also examines the acute effects of different types and intensities of physical exercise on tinnitus perception, and performs psychometric validation of Czech-language tinnitus assessment questionnaires.
Participants (N=160, aged 18-70 years) will be randomly assigned to either the multimodal intervention group (8 weeks, 5 sessions/week) or a control group. Follow-up assessments will be conducted at 3, 12, and 24 months. The primary outcome is the change in the Tinnitus Handicap Inventory (THI) score.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-70 years (inclusive)
* Chronic subjective tinnitus present for ≥6 months
* Tinnitus Handicap Inventory (THI) score ≥18 points (indicating at least mild tinnitus handicap)
* Positive somatosensory modulation test: ability to reproducibly modulate tinnitus (change in loudness, pitch, or quality) through at least one of the following manoeuvres:
* Jaw movements (mouth opening, lateral excursion, protrusion, clenching)
* Neck movements (flexion, extension, rotation, lateral flexion)
* Pressure on specific head/neck muscles
* Eye movements or shoulder elevation
* Willing and able to attend all study sessions over 28 weeks
* Adequate cognitive capacity to understand study procedures and complete questionnaires in the Czech language
* Signed written informed consent
Exclusion Criteria:
* Audiological/ENT Exclusions:
* Objective or pulsatile tinnitus
* Active ear pathology requiring treatment:
* Acute otitis media or externa
* Chronic suppurative otitis media
* Cholesteatoma
* Meniere's disease with recent vertigo attacks (\<3 months)
* Suspected retrocochlear pathology:
* Acoustic neuroma (vestibular schwannoma)
* Cerebellopontine angle tumor
* Neurological Exclusions:
* Neurological disease affecting brainstem or auditory pathways:
* Multiple sclerosis with brainstem involvement
* Stroke affecting auditory pathways
* Brain tumor
* Epilepsy or active seizure disorder
* Musculoskeletal Exclusions:
* Contraindications to manual therapy:
* Severe cervica…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Tinnitus Handicap Inventory (THI) score
Timeframe: Baseline, 4 weeks, 8 weeks (end of intervention), 3 months, 12 months, and 24 months.